Diabetes Mellitus, Type 2NCT04630691
Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients
An observational study of Diabetes Mellitus, Type 2 and Implant Complication, run by University of Witten/Herdecke.
Trial summary
The aim of the present study was to compare the initial healing and long term performance of narrow diameter implants in patients with uncontrolled Diabetes mellitus type 2 (T2DM) and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Implant Complication
- What is being tested?
- Implantation
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2012to 1 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All
Who may be able to join
- Patients with one or more missing teeth posterior to the canine either in the maxilla or mandible and associated with diminished alveolar ridge dimensions were included in the study
Who cannot join
- immobility of diabetic patients
- periodontal surgery and/or antibiotic therapy within the last 6 months prior to baseline
- pregnancy and lactation period
- Full Mouth Plaque Score (FMPS) > 25%
- untreated periodontitis
- smoking > 10 cigarettes/day
Show all 9Show fewer
- insufficient crestal volume making an augmentation procedure necessary
- previously performed ridge augmentation procedure for a staged implant placement
- permanent medication potentially affecting blood perfusion rate and bone metabolism
About this study
Official title: Evaluation of Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients
The aim of the present study was to compare the initial healing and long term performance of narrow diameter implants in patients with uncontrolled Diabetes mellitus type 2 (T2DM) and healthy individuals.
- Conditions
- Diabetes Mellitus, Type 2, Implant Complication
- Being tested
- Implantation
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplantationProcedure or surgery
Patients received narrow diameter implants in posterior mandible or maxilla
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients with HbA1c around 6,0 Receives: Procedure: Implantation | |
| T2DM | Patients with HbA1c above 6,5 Receives: Procedure: Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
No difference
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start1 Dec 2012
- Primary completion1 Dec 2016
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witten/Herdecke
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630691
- Sponsor's protocol ID
- UWHPerioT2DM
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Diehl D, Bespalov A, Yildiz MS, Friedmann A. Restoration of posterior teeth by narrow diameter implants in hyperglycemic and normoglycemic patients - 4-year results of a case-control study. Clin Oral Investig. 2024 Jun 22;28(7):392. doi: 10.1007/s00784-024-05786-0.
PubMed 38907052Diehl D, Kaner D, Bockholt A, Bilhan H, Friedmann A. Microcirculation and neutrophil-related cytokine concentrations are not altered around narrow diameter implants in T2DM patients during wound healing. Clin Oral Investig. 2023 Mar;27(3):1167-1175. doi: 10.1007/s00784-022-04731-3. Epub 2022 Oct 13.
PubMed 36229741Friedmann A, Winkler M, Diehl D, Yildiz MS, Bilhan H. One-year performance of posterior narrow diameter implants in hyperglycemic and normo-glycemic patients-a pilot study. Clin Oral Investig. 2021 Dec;25(12):6707-6715. doi: 10.1007/s00784-021-03957-x. Epub 2021 May 3.
PubMed 33939006
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Posterior Narrow Diameter Implants in Hyperglycemic and Normo-glycemic Patients
- ClinicalTrials.gov ID
- NCT04630691
- Acronym / sponsor ID
- UWHPerioT2DM
- Conditions
- Diabetes Mellitus, Type 2, Implant Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Witten/HerdeckeUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 1 Dec 2012 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to compare the initial healing and long term performance of narrow diameter implants in patients with uncontrolled Diabetes mellitus type 2 (T2DM) and healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: ImplantationPatients with HbA1c around 6,0 |
| T2DM | – | Procedure: ImplantationPatients with HbA1c above 6,5 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All
Key inclusion criteria (1 listed)
- Patients with one or more missing teeth posterior to the canine either in the maxilla or mandible and associated with diminished alveolar ridge dimensions were included in the study
Key exclusion criteria (9 listed)
- immobility of diabetic patients
- periodontal surgery and/or antibiotic therapy within the last 6 months prior to baseline
- pregnancy and lactation period
- Full Mouth Plaque Score (FMPS) > 25%
- untreated periodontitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImplantationPatients received narrow diameter implants in posterior mandible or maxilla | Procedure or surgery | Control, T2DM |
Primary outcome
No difference
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Derived from this study: PubMed 38907052Diehl D, Bespalov A, Yildiz MS, Friedmann A. Restoration of posterior teeth by narrow diameter implants in hyperglycemic and normoglycemic patients - 4-year results of a case-control study. Clin Oral Investig. 2024 Jun 22;28(7):392. doi: 10.1007/s00784-024-05786-0.
- Derived from this study: PubMed 36229741Diehl D, Kaner D, Bockholt A, Bilhan H, Friedmann A. Microcirculation and neutrophil-related cytokine concentrations are not altered around narrow diameter implants in T2DM patients during wound healing. Clin Oral Investig. 2023 Mar;27(3):1167-1175. doi: 10.1007/s00784-022-04731-3. Epub 2022 Oct 13.
- Derived from this study: PubMed 33939006Friedmann A, Winkler M, Diehl D, Yildiz MS, Bilhan H. One-year performance of posterior narrow diameter implants in hyperglycemic and normo-glycemic patients-a pilot study. Clin Oral Investig. 2021 Dec;25(12):6707-6715. doi: 10.1007/s00784-021-03957-x. Epub 2021 May 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Implant Complication, run by University of Witten/Herdecke.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No difference (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04630691, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.